Paper
Analysis of Adverse Events of Bortezomib Therapy in Patients with Multiple Myeloma
Published Jun 10, 2009 · Nobutsugu Waga, N. Ogasawara, K. Okada
Japanese Journal of Pharmaceutical Health Care and Sciences
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Abstract
わが国の悪性新生物による死亡者数は約 33 万人(厚生 労働省,平成 19 年人口動態統計)であり,そのうち多発 性骨髄腫の死亡者数の全がんに占める割合は約 1%であ る. 多発性骨髄腫の病態は,造血抑制(感染,貧血,出血), 免疫グロブリンM蛋白の大量産生(腎障害,眼症状,神 経障害)および骨病変(骨痛,骨折,高Ca血症)を三大徴 候とし,このうち骨病変は,破骨細胞の活性化による骨 吸収の亢進と,骨芽細胞の分化抑制による骨形成の阻害 により,全身骨X線検査において,骨抜き打ち像 (punched-out lesion)が特徴的にみられる.また,M蛋 白量が病勢の指標となり,β2―マイクログロブリン値が 予後因子となる. 多発性骨髄腫に対する治療の変遷は,進行期例に対し て 1960 年代に確立したMP(Melphalan,Prednisolone)療 法と,再発例に対する救援療法として 1980 年代に開発 されたVAD(Vincristine,Adriamycin,Dexamethasone)療 法,そして 1990 年代後半には医師の個人輸入という形 でサリドマイドが投与されてきた.一方,自己造血幹細 胞移殖併用大量化学療法が 65 歳未満の若年者における 標準治療として従来の化学療法による治療成績を上回る ことが報告されてきた.しかし,これらの治療によっ ても完全寛解が得られない場合があり,また,長期的に は再発・再燃をきたすことも多く,より安全で有効な新 規治療薬の開発が待たれてきた. 2006 年 12 月にプロテアソーム阻害剤であるボルテゾ ミブ(ベルケイド ,ヤンセンファーマ(株),BOR)が承認 In the present study, the authors retrospectively reviewed the incidence and severity of hematotoxicity and nonhematotoxicity in 5 in-patients with multiple myeloma who underwent Bortezomib therapy at Iwate Prefectural Central Hospital. Bortezomib is the first proteasome inhibitor to be approved for the treatment of refractory or relapsed multiple myeloma. We evaluated the efficacy of Bortezomib therapy at the same time. As for hematoxicity, severe adverse events defined as grade 3 or 4 in the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v.3.0) were observed in all patients. In cases of thrombocytopenia, the platelet count tended to decrease synchronously following injections and return to normal in injection off-periods. Regarding non-hematotoxicity, the subjective symptoms of insomnia, constipation, nausea, peripheral neuropathy, and dullness occurred at high frequencies. Two patients had the dose of Botezomib reduced since their adverse events included peripheral neuropathy. Previously unknown adverse events also occurred. Our findings suggested that great caution should be exercised in administering prior therapy as well as to changes in platelet counts related to adverse events which may occur during Bortezomib therapy. Furthermore, based on the M protein values observed and the fact that β2-microglobulin decreased in all cases, Bortezomib appeared to have high efficacy.
Bortezomib therapy for multiple myeloma shows high efficacy, but caution is needed in managing hematotoxicity and nonhematotoxicity.
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